This Core will provide cornprehensive and centralized statistical support to all components within the SPORE, and address explicit issues including statistical study design, data analysis and data management for preclinical and clinical studies.
The specific aims of this Core are to: Aim 1 : To coordinate and manage statistical activities to ensure that all SPORE investigators have ready and dedicated access to biostatistical consultation, data analysis and reporting; Aim 2 : To provide expertise in statistical design, planning and conduct of clinical trials and preclinical studies including data review, quality control and protocol compliance; Aim 3 : To provide comprehensive support for data analysis including safety/toxicity/futility/efficacy monitoring, interim reviews of data, final analysis, interpretation and reporting; Aim 4 : To coordinate data management activities in close collaboration with the Clinical Research Core. Centralized biostatistical support (a) facilitates continuation and efficient use of biostatistical services, (b) provides an opportunity for dynamic collaboration between biostatisticians and investigators in the design, conduct, analysis and interpretation of results for all projects, and (c) ensures the conduct of high-quality projects that incorporate from the design stage appropriate and state-of-the-art statistical methods. For all types of research data (human, mouse, cell line, etc), the core can execute planned analyses efficiently. The core has a dedicated and experienced team of biostatisticians devoted to this research effort, which can flexibly and efficiently shift from one project to the next. Core personnel will help the investigators design new studies and test new hypotheses that may arise by the interactions of related projects. Data management activities for all clinical studies (phase 1 trials for all projects) will be highly coordinated between the Biostatistics Core and the Clinical Research Core B to ensure appropriate data collection and sufficient quality control while maintaining efficiency in the conduct of these activities.

Public Health Relevance

This is a continuation of an existing and well-functioning Core that provides an essential infrastructure for close collaboration and interactions between biostatisticians and SPORE investigators. All SPORE projects will require substantial statistical support for preclinical experiments and clinical trials. The Core infrastructure will insure implementation of innovative and high-quality SPORE translational studies.